PEPconnect

IVDR Essentials for Manufacturers

The IVDR Essentials for Manufacturers consists of two parts: IVDR Overview and topics specifically related for Manufacturers and Distributors. These are brought into the correct depth specific for IVD manufacturers and their organizations, providing IVDs on the market. This training is delivered in two parts: Materials for IVDR Overview are provided for download and self-study, and the second part is delivered as live event with an instructor.

Estimated Duration: 4.5 hours live, plus time for self-study

Price - 600€ plus VAT - Your local country Education team will contact you for processing the payment.

  • IVDR
  • MDR
  • product classification
  • notified body/bodies
  • technical file
  • UDI relevance
  • performance evaluation
  • product registration
  • post market surveillance